Operations Compliance Lead

Pfizer • Sanford, MA

10d • Hybrid

About The Position

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or research analysis, your contributions are vital and directly impact patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. As the Director of Quality Assurance within the Global Supply division, you will play a pivotal role in improving patients' lives by ensuring the highest standards of quality and safety in our products. Your leadership and expertise will drive the growth of our Quality Assurance team, fostering a culture of innovation and excellence that directly impacts the well-being of patients worldwide.

Requirements

• Applicant must have a bachelor's degree with at least 8 years of experience; OR a master's degree with at least 7 years of experience; OR a PhD with 5+ years of experience
• Proven technical knowledge and expertise in root cause analysis (RCA) and CAPA activities
• Demonstrated in-depth understanding of global regulations, guidelines, and evolving legislation
• Excellent organizational, analytical, strategic, interpersonal, written, and oral communication skills
• Thorough understanding and application of cGMP principles, relevant quality processes, systems, and Country Specific Standards
• Experience in developing and leading complex projects and mid-term plans
• Ability to make decisions in complex problems and identify innovative solutions
• Permanent work authorization in the United States.

Nice To Haves

• Proficiency in engaging with FDA, EU investigators, and other regulatory bodies during audits
• Profound grasp of compliance and quality management, including the necessary procedures and audit readiness requirements
• Extensive experience within regulated environments, encompassing policies, procedures, and processes
• Strong leadership and team-building skills
• Ability to influence and partner with cross-functional leadership
• Excellent problem-solving and decision-making abilities
• Strong project management skills
• Ability to foster a culture of innovation and continuous improvement
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Responsibilities

• Develop and lead/co-lead highly complex projects, creating mid-term plans that impact results.
• Leverage relationships to meet the needs of various business units, serving as an advisor to others.
• Make decisions in complex problems, identifying innovative solutions, and recommending courses of action that influence management and senior staff decisions.
• Act independently on self-initiated projects, utilizing knowledge from others and exercising judgment in complex decisions.
• Review work for effectiveness and business impact, and evaluate the work of colleagues.
• Exercise foresight and judgment using knowledge and experience within the business unit.
• Develop innovative ideas and lead complex business unit projects.
• Act as an enterprise leader in Quality, partnering with business leadership to develop and strengthen a holistic Quality Management System.
• Innovate to create new strategies and solutions that improve the business unit's value and contribution to the enterprise.
• Partner with cross-functional leadership to develop strategies, identify risks, provide guidance, and oversee mitigations across global functions.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior